The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

Ovulation Clinical Trial

Official title:

The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129245
• Other study ID #: OHSU FAMPLAN SFP3-7
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: May 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.

Description:

A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.

This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 18-35

• Currently NOT using hormonal contraception

• Cycle length between 26-34 days

• General good health (specifically no hx of: diabetes, cardiac problems, moderate/severe heart burn (GERD), obesity (BMI > 30), hypertension (BP > 130/80)

• Willing and able to agree to randomization and informed consent

• Willing and able to use a menstrual diary to chart bleeding Serum progesterone > 3 ng/ml (from cycle day 18-25)

• Willing and able to return to clinic for bi-weekly for blood tests and ultrasounds throughout cycles 2, 3 & 5

Exclusion Criteria:

• Diabetes

• Cardiac disease

• Moderate to severe heart burn (or GERD) Obesity (BMI > 30) Hypertension (BP > 130/80)

• Allergy to NSAIDS

• Currently pregnant or trying to conceive

• Polycystic Ovarian Syndrome

• Use of hormonal contraception (participants can use barrier methods, spermicide, female or male sterilization, copper intrauterine device, abstinence, or have female partners

Related Conditions & MeSH terms

• Luteal Development
• Ovulation

Intervention

Drug:
• Celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
• Placebo
Placebo identical to celecoxib

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (1)

Edelman AB, Jensen JT, Doom C, Hennebold JD. Impact of the prostaglandin synthase-2 inhibitor celecoxib on ovulation and luteal events in women. Contraception. 2013 Mar;87(3):352-7. doi: 10.1016/j.contraception.2012.07.004. Epub 2012 Aug 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase	One cycle corresponds to one participant	4 cycles (approximately 4 months)
Secondary	Peak Hormone Levels	Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.	4 cycles (approximately 4 months)
Secondary	Peak Estradiol Level	Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.	4 cycles (approximately 4 months)

External Links

•   Author Manuscript